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Method for treating stage iv melanoma

Active Publication Date: 2010-09-02
COVSEY VACCINES PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013]The present invention also provides a method of improving the rate of survival of a subject with Stage IV melanoma, the method including the step of administering to the subject a therapeutically effective amount of a melanoma cell lysate and / or an immunotherapeutic extract, component or antigen thereof.
[0014]The present invention also provides a method of increasing life expectancy of a subject with Stage IV melanoma, the method including the step of administering to the subject a therapeutically effective amount of a melanoma cell lysate and / or an immunotherapeutic extract, component or antigen thereof.
[0023]The present invention arises from clinical studies into the use of a Vaccinia Melanoma Cell Lysate (VMCL) vaccine to treat patients with Stage IV metastatic melanoma. The cell lysate is prepared from a melanoma cell line. The studies show that VMCL vaccine appears to be effective in slowing melanoma growth in over 50% of patients and inducing complete regression of tumour in about 25% of patients with advanced “incurable” Stage IV metastatic melanoma. These are patients for which no other effective treatment currently exists. The vaccine also provides a non-toxic avenue for treatment of patients with Stage IV melanoma.
[0029]The term “treat” and variants thereof as used throughout the specification is to be understood to mean therapeutic intervention with a melanoma cell lysate (and / or an immunotherapeutic extract, component or antigen thereof) of the present invention. For example, the term includes within its scope the therapeutic intervention with the melanoma lysate to have one or more of the following outcomes: (i) inhibit or prevent the growth of the primary tumour in a subject, including reducing the growth of the primary tumour after resection; (ii) inhibit or prevent the growth and formation of one or more secondary tumours in a subject, including tumours in the lymph nodes; (iii) improve the life expectancy of the subject as compared to the untreated state; and (iv) improve the quality of life the subject as compared to the untreated state.

Problems solved by technology

Surgery for isolated metastases is an option for a subgroup of patients with Stage IV melanoma, and occasionally chemotherapy can be effective in specific instances, but these options are usually not available for widespread metastatic disease and response rates to any form of standard therapy are almost universally non-existent.
Despite many studies relating to the development of therapeutic interventions for melanoma, there has been little progress in this field.
Indeed, apart from surgical intervention and the use of chemotherapeutic agents, there is no effective treatment for Stage IV melanoma.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Vaccine Preparation

[0147]Vaccine preparation was carried out as in Hersey et al (1987) Cancer Immunol. Immunother 25:257-265, using methods similar to those described by Wallack et al. (1998) J. Am. Coll. Surg. 187:69-77 and Wallack et al (1986) Cancer 57:649-655.

[0148]A single allogeneic melanoma cell line, referred to as MM200 (Pope et al. (1979) Pathology 11:191-195), was infected with vaccinia virus (prepared by Commonwealth Serum Laboratories, Melbourne, Australia) at 2.5 pock-forming units / cell. MM200 was originally isolated from a primary melanoma on a 43-year-old woman in 1972 but no other patient details are available. The HLA type was A1,3; B7,35; DR2,4. Chromosomal analysis showed a nodal number of 76, and a number of marker chromosomes were revealed by karyotypic analysis (Muir and Gunz (1979) Pathology 11:597-606).

[0149]The vaccinia virus was the strain referred to as strain O, which was derived in 1921 from two strains imported from the Lister Institute in 1912 and a s...

example 2

Administration Regime

[0150]The VMCL vaccine protocol (vaccination with 0.1-0.5 ml of the lysate) specified 2 weekly vaccinations for 5 cycles, monthly for 4 cycles and then 3 monthly for as long as a measurable observable clinical response was present. Chemotherapy was used for some patients who developed progressive disease despite vaccine therapy. Where chemotherapy was used with VMCL vaccine, the schedule was modified slightly to administer the vaccine in the 1-2 weeks prior to each DTIC dose (given in standard 3 weekly cycles), with the aim of induction of an immune response prior to leukocyte nadir at about 7-10 days. The use of chemotherapy was determined by the patient's condition and consent. The effect was assessed after 3 doses, with CT scans, before a further 3 doses were given.

[0151]Patients were given the vaccine by intradermal injection over the deltoids or on the anteromedial aspect of the thighs, rotating to a different site with each injection. The first injection w...

example 3

VMCL Stage IV Melanoma Pilot Clinical Study

[0153]Data has been obtained for 20 patients with advanced Stage IV Melanoma treated with the VMCL vaccine. These patients would ordinarily be considered to have “incurable” metastatic disease, beyond the capacity for surgical resection of metastases. A range of metastatic sites were present in these patients including subcutaneous, lung, brain, liver, bone and bowel. Patients with brain metastases were excluded at entry. However, if cerebral metastases developed during the study these were then resected where possible and adjuvant radiotherapy was used post-surgery. These patients were then re-induced with VMCL vaccine after recovery, repeating the initial protocol. Several patients with prior resected and treated cerebral metastases were included.

[0154]As discussed above, the VMCL vaccine protocol specified 2 weekly vaccinations for 5 cycles, monthly for 4 cycles and then 3 monthly for as long as a measurable observable clinical response ...

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Abstract

The present invention relates to a method of treating Stage IV melanoma in a subject. The method includes the step of administering to the subject a therapeutically effective amount of a melanoma cell lysate and / or an immunotherapeutic extract, component or antigen thereof.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a method of treating Stage IV melanoma in a subject, and to a combination product for treating Stage IV melanoma.[0002]The present invention further relates to methods for inhibiting formation and / or growth of tumours in a subject with Stage IV melanoma, improving the rate of survival / life expectancy of a subject with Stage IV melanoma, and inducing an anti-tumour immune response in a subject with Stage IV melanoma.[0003]The present invention also relates to a method of selecting a subject with Stage IV melanoma suitable for treatment.BACKGROUND OF THE INVENTION[0004]Melanoma is a malignant tumor of melanocytes, cells that are derived from the neural crest. Melanoma can spread by local extension (through lymphatics) and / or by hematogenous routes to distant sites. Any organ may be the site for metastases, but lungs and liver are common sites.[0005]In humans subjects, clinical staging of melanoma is based on whether the tumo...

Claims

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Application Information

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IPC IPC(8): A61K39/00A61P35/00A61K35/768
CPCA61K39/0011A61K2039/5152A61K31/00A61K35/768A61K2300/00A61P35/00A61P37/04A61K2039/876A61K39/00119A61K35/36A61K45/06A61K2039/545
Inventor HERSEY, PETERCOVENTRY, BRENDON JOHN
Owner COVSEY VACCINES PTY LTD
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